Drug safety evaluation
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Shayne C Gad
- ناشر : New York : J. Wiley,
- چاپ و سال / کشور: 2002
- شابک / ISBN : 9780471459293
Description
Strategy and phasing for drug safety evaluation in the discovery and development of pharmaceuticals -- Regulation of human pharmaceutical safety -- Information sources: Building and maintaining data files -- screens in safety and hazard assessment -- Acute toxicity testing in drug safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity studies -- Developmental and reproductive toxicity testing -- Carcinogenicity studies -- Safety assessment of inhalant drugs -- Irritation and local tissue tolerance in pharmaceutical safety assessment -- Special concerns for the preclinical evaluation of biotechnology products -- Formulations, routes, and dosage designs -- Occupational toxicology in the pharmaceutical industry -- Immunotoxicology in pharmaceutical development -- Large animal studies -- The application of in vitro techniques in drug safety assessment -- Pharmacokinetics and toxicokinetics in drug safety evaluation -- Safety pharmacology -- Evaluation of human tolerance and safety in clinical trials: Phase I and beyond -- Postmarketing safety evaluation: Monitoring, assessing, and reporting of adverse drug responses (ADRs)
